Applied Clinical Trials has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.

10-January-2019 at UTC 1600

Facilitator:Hugo Cervantes, Vice President Vault CDMS, Veeva

Learn how top pharmaceutical companies and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.

11-October-2018 via webinar (one hour)

Facilitator: Dr. Jules Mitchel, Target Health

With drug and device manufacturers and the U.S. Food and Drug Administration (FDA) supplying much of the push, so-called paperless clinical trials are gaining momentum. We will discuss the future landscape and regulatory concerns of paperless clinical trials and clinical trial design incorporating mobile tools.

Date: Wed, 25 July 2018 Duration: One hour

Facilitator: Shelby Abel, Bioverativ a Sanofi Company

For This Topic: “Experience with exceptions of PI signature/Approval on eCOA Data. Please bring your experience and thoughts.” This is a facilitated discussion with the content coming from the sharing of participants experiences, comments, and questions on this topic.

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation… Expand article to read more...

Partnering for Success

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes. This is not eSRA -- it is a voluntary survey -- it is not an assessment. (If you are looking for eSRA, please download the Handbook below). GO TO THE SURVEY. Expand the article to read more...

Not a member?
Visit the Membership page to learn How To Become a Member (Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)

Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.

The link/survey will only be active until the end of May 2019, but we encourage you to complete the survey before Friday, February 22 2019, as we need the information to improve the eSRA Version 2019 which will be available the first week of March. Responses after Feb 22, 2019 will be considered for the 2020 version.

Sites -- If you would like to provide feedback for the eSRA V2019, please describe your feedback in an email to esra@eclinicalforum.org

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org to suggest topics or get registration information.

Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.

Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions" "People were amazing. Topics were great"